Nevro Corp.

Patent Trials and Appeals Board

Jun 9, 2021

IPR2021-00295 (P.T.A.B. Jun. 9, 2021)

Trials@uspto.gov Paper 16
571-272-7822 Date: June 9, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

BOSTON SCIENTIFIC CORP., AND BOSTON SCIENTIFIC
NEUROMODULATION CORP.,
Petitioner,
v.
NEVRO CORP.,
Patent Owner.

IPR2021-00295
Patent 9,002,461 B2

Before BARRY L. GROSSMAN, MITCHELL G. WEATHERLY, and
JAMES A. WORTH, Administrative Patent Judges.
WORTH, Administrative Patent Judge.
DECISION
Denying Institution of Inter Partes Review
35 U.S.C. § 314
I. INTRODUCTION
A. Background and Summary
On December 7, 2020, Boston Scientific Corp. and Boston Scientific
Neuromodulation Corp. (collectively, “Boston Scientific” or “Petitioner”)
filed a Petition (Paper 1, “Pet.”) requesting an inter partes review of
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claims 1–8 and 10–17 (the “challenged claims”) of U.S. Patent No.
9,002,461 B2 (Ex. 1001, “the ’461 patent”). On March 15, 2021, Nevro
Corp. (“Nevro” or “Patent Owner”) filed a Preliminary Response (Paper 9,
“Prelim. Resp.”). With authorization, the parties filed further pre-institution
briefing related to the issue of discretion under 35 U.S.C. § 314(a), as
follows. On April 5, 2021, Petitioner filed a reply to the Preliminary
Response. Paper 11. On April 12, 2021, Patent Owner filed a sur-reply.
Paper 13. On May 25, 2021, Petitioner filed a second reply to the
Preliminary Response. Paper 14.
Petitioner relies on the declaration of Richard T. Mihran, Ph.D.
Ex. 1008.
Institution of an inter partes review is authorized by statute when “the
information presented in the petition filed under [35 U.S.C. §] 311 and any
response filed under [35 U.S.C. §] 313 shows that there is a reasonable
likelihood that the petitioner would prevail with respect to at least 1 of the
claims challenged in the petition.” 35 U.S.C. § 314(a) (2018).
For the reasons set forth below, we determine that Petitioner has not
shown that there is a reasonable likelihood that any of claims 1–8 and 10–17
is unpatentable based on the Petition, and we deny the Petition. In
particular, we determine that Petitioner has not shown a reasonable
likelihood that any of the prior art discloses the following limitation of
independent claim 1, “automatically set the waveform parameter applied to
the second electrode based on a relationship between the first therapy range
and the second therapy range” (referred to below as limitation 1[h]). More
particularly, Petitioner has not adequately explained how the claim language
maps onto the cited prior art. Independent claim 11 contains a
corresponding limitation. Petitioner’s argued grounds of anticipation and
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obviousness are therefore deficient. We explore Petitioner’s argued grounds
in more detail below.
B. Real Parties in Interest
Petitioner identifies Boston Scientific Corp. and Boston Scientific
Neuromodulation Corp. as real parties-in-interest. See Pet. 1. Patent Owner
identifies Nevro Corp. as a real-party-in-interest. Paper 4, 1.
C. Related Matters
The parties note as related litigation in federal district court, Boston
Scientific Corp. et al v. Nevro Corp., Nos. 16-cv-1163, 18-cv-00644
(consolidated) (D. Del.). See Pet. 1; Paper 4, 1. Petitioner has filed a
petition for inter partes review challenging U.S. Patent No. 9,002,460
(IPR2021-01562) and U.S. Patent No. 10,076,665 (IPR2020-01563). See
Pet. 1; Prelim. Resp. 11. According to Patent Owner, the ’461 patent is
related to the following other patents and applications: 8,712,535, 8,498,710,
9,409,019, 9,827,423, 10,220,210, 10,786,672, and 16/944,841. Paper 4, 1.
D. The ’461 Patent
The ’461 patent is titled “Linked Area Parameter Adjustment for
Spinal Cord Stimulation and Associated Systems and Methods” and is
directed “to spinal cord stimulation for managing pain, and associated
systems and methods related to adjusting the amplitude, duty cycle and/or
other parameters of the electrical waveform applied to the patient.”
Ex. 1001, 1:21–25.
The ’461 patent describes that then-existing pulse generator devices
applied electrical pulses to electrodes, which altered a patient’s
responsiveness to sensory stimuli and/or altered the patient’s nervous
system’s motor-circuit output. Id. at 1:44–48. The ’461 patent describes
that many patients reported tingling or paresthesia that was perceived as less
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uncomfortable than the patients’ underlying pain sensation, but many other
patients reported less beneficial effects and/or results. Id. at 1:50–54. The
’461 patent thus describes a need for improved techniques and systems for
addressing pain. Id. at 1:55–56. According to the ’461 patent, one particular
challenge of implementing neurological stimulators to manage pain was that
multiple parts or regions of the patient’s body contribute to the pain
perceived by the patient, and the individual contributions of the various
regions vary over time. Id. at 1:57–61.
Figure 1A of the ’461 patent is reproduced below:

Figure 1A is a partially schematic illustration of an implantable spinal
cord stimulation system positioned at the spine to deliver therapeutic signals.
Id. at 2:3–6. Waveform generator 101 can be connected directly to lead
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body 110, or it can be coupled to lead body 110 via communication link 102
(e.g., an extension). Id. at 5:5–8.
The ’461 patent discloses that during the trial period and the course of
the spinal cord stimulation (SCS) therapy itself, the patients typically change
the parameters of the waveforms applied to different areas along the spinal
cord to optimize the therapy. Id. at 2:61–64. In some embodiments, the
present technology includes an electrode device having a plurality of
electrodes including at least a first electrode associated with a first area of
the patient and a second electrode associated with a second area of the
patient. The first area has a first therapy range for a waveform parameter,
and the second area has a second therapy range for the waveform parameter.
Id. at 3:29–31.
The level of a waveform parameter applied to each area in a linked
pair can be modulated based upon a scaling factor between the
corresponding areas. Id. at 6:41–44.
The ’461 patent discloses that when the amplitude is the waveform
parameter being modulated, the ratio of the first therapy range for the first
area of the patient to the second therapy range for the second area of the
patient can be defined by the equation:

Ex. 1001, 10:66–11:7. In this equation, A1P is the amplitude at which the
patient experiences pain at the first area, A1T is the amplitude at which the
patient experiences a therapeutic effect at the first area, A2P is the amplitude
at which the patient experiences pain at the second area, and A2T is the
amplitude at which the patient experiences a therapeutic effect at the second
area. Id. at 11:8–14. In this embodiment, the change in the level of the
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waveform parameter applied to the second area is the product of the
magnitude of the first increment that the waveform parameter was changed
at the first area and the ratio of the first therapy range to the second therapy
range. Id. at 11:14–19.
By way of an example where there is a ratio of a first therapy range to
a second therapy range of 3:2, each time the patient pushes a button to
increase or decrease the waveform parameter, the waveform parameter for
the first electrode is changed by a full increment, but the waveform
parameter is changed at the second area only every two out of three times
that the patient pushes the button. See id. at 11:47–58.
In one particular example, the computer program is programmed to
change the level of the waveform parameter applied to the first electrode
implanted at the first area of the patient to an updated first level,
automatically set the second level of the waveform parameter based on a
ratio or other relationship between the first therapy range and the second
therapy range to an updated second level, and deliver the electrical
waveform at the updated first level to the first electrode and at the updated
second level to the second electrode. Id. at 4:36–45.
In several embodiments, the method includes changing the level of the
waveform parameter applied to the first electrode and concurrently setting
the level of the waveform parameter applied to the second electrode, but in
other embodiments there can be a delay between changing the level of the
waveform parameter applied to the first electrode and setting the level of the
waveform parameter applied to the second electrode. Id. at 7:47–54.
E. Illustrative Claim
Claims 1 and 11 are the independent claims challenged in the Petition.
Claim 1, reproduced below, is illustrative of the subject matter:
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1. [a] A system for managing pain in a patient using an
electrical waveform, comprising:
[b] an electrode device configured to be implanted into a
patient and including a plurality of electrodes
[c] having at least a first electrode associated with a first
area of the patient and a second electrode associated with a
second area of the patient,
[d] wherein the first area has a first therapy range for a
waveform parameter and the second area has a second therapy
range for the waveform parameter; and
[e] an implantable device configured to be coupled to the
electrode device,
[f] the implantable device including a power supply, a
waveform generator configured to generate a waveform, and a
computer-operable medium operatively coupled to the waveform
generator,
[g] the computer-operable medium being programmed to
change the waveform parameter applied to the first electrode and
[h] automatically set the waveform parameter applied to
the second electrode based on a relationship between the first
therapy range and the second therapy range.

Ex. 1001, 14:12–31 (reproduced with added paragraphing and paragraph
letter designations in brackets).
F. Prior Art and Asserted Grounds
Petitioner asserts that claims 1–8 and 10–17 would have been
unpatentable on the following 23 grounds (Pet. 4–5):
Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis
1–4, 7, 8, 10–17 102 Meadows1

1 Meadows, US 6,516,227 B1, iss. Feb. 4, 2003 (Ex. 1003, “Meadows”).
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Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis
1–8, 10–17 1032 Meadows
1–8, 10–17 103 Meadows, John3
6–8 103 Meadows, Goetz4
6–8 103 Meadows, John, Goetz
1–4, 7, 8, 10–17 102 Thacker5
1–8, 10–17 103 Thacker
1–8, 10–17 103 Thacker, Meadows
1–8, 10–17 103 Thacker, John
1–8, 10–17 103 Thacker, Meadows, John
6–8 103 Thacker, Goetz
6–8 103 Thacker, Meadows, Goetz
6–8 103 Thacker, John, Goetz
6–8 103 Thacker, Meadows, John, Goetz
1–4, 10–17 102 Nolan6
1–8, 10–17 103 Nolan
1–8, 10–17 103 Nolan, Meadows
1–8, 10–17 103 Nolan, John
1–8, 10–17 103 Nolan, Meadows, John
6–8 103 Nolan, Goetz
6–8 103 Nolan, Meadows, Goetz
6–8 103 Nolan, John, Goetz
6–8 103 Nolan, Meadows, John, Goetz

We observe that several of the 23 grounds were argued in the
alternative. For example, the asserted ground of anticipation by Meadows

2 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
Stat. 284, 287–88 (2011), amended 35 U.S.C. §§ 102 and 103. It is
undisputed on this record that the priority date of the ’461 patent is July 28,
2009. See Pet. 14; Prelim. Resp. 5. Because the ’461 patent was filed
before the effective date of the relevant amendment, the pre-AIA version of
§§ 102 and 103 applies.
3 John, US 2007 /0043401 A1, pub. Feb. 22, 2007 (Ex. 1006, “John”).
4 Goetz, US 2006/0235472 A1, pub. Oct. 19, 2006 (Ex. 1007, “Goetz”).
5 Thacker, US 9,278,222 B2, iss. Mar. 8, 2016 (Ex. 1004, “Thacker”).
6 Nolan, US 2007/0213789 A1, pub. Sept. 13, 2007 (Ex. 1005, “Nolan”).
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was based on two argued scenarios and “in addition . . . other ways” in
which Meadows is argued to disclose a limitation. See Pet. 32–35. Further,
the asserted grounds of anticipation by Thacker, obviousness over Thacker,
and obviousness over Meadows were argued based on Thacker’s system
implementing an aspect of Meadows or Meadows’s system using a feature
of Thacker. See, e.g., Pet. 59. Thus, there are in effect more than 23 argued
grounds. Nevertheless, for purposes of the above summary chart, we have
summarized the asserted grounds as the 23 grounds listed above.7
II. ANALYSIS
A. Legal Standards
A “prior art reference—in order to anticipate under 35 U.S.C. § 102—
must not only disclose all elements of the claim within the four corners of
the document, but must also disclose those elements ‘arranged as in the
claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir.
2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed.
Cir. 1983)). “A single prior art reference may anticipate without disclosing
a feature of the claimed invention if such feature is necessarily present, or
inherent, in that reference.” Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 958
(Fed. Cir. 2014).
“[A]nticipation by inherent disclosure is appropriate only when the
[single prior art] reference discloses prior art that must necessarily include
the unstated limitation.” Transclean Corp. v. Bridgewood Servs., Inc., 290

7 We note that the Petitioner also had multiple theories of the case inasmuch
as the asserted grounds were characterized by string citations to numerous
portions of the record. Some of these citations spanned columns of text.
See, e.g., Pet. 33 (citing Ex. 1012, 12:10–15:16, 16:3–18:2, 20:5–24:24), 80
(citing Ex. 1005 ¶¶ 52–69, 78–98), 81 (citing id. at claims 1–17, 32–38).
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F.3d 1364, 1373 (Fed. Cir. 2002) (citation omitted). “Inherency . . . may not
be established by probabilities or possibilities. The mere fact that a certain
thing may result from a given set of circumstances is not sufficient.” Cont’l
Can Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264, 1269 (Fed. Cir. 1991)
(internal quotation marks and citations omitted). Rather, “[t]he inherent
result must inevitably result from the disclosed steps.” In re Montgomery,
677 F.3d 1375, 1380 (Fed. Cir. 2012).
A patent claim is unpatentable under 35 U.S.C. § 103 if the
differences between the claimed subject matter and the prior art are such that
the subject matter, as a whole, would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains. 35 U.S.C. § 103; KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 406 (2007). “[W]hen a patent claims a structure already known in
the prior art that is altered by the mere substitution of one element for
another known in the field, the combination must do more than yield a
predictable result.” KSR, 550 U.S. at 416 (citing United States v. Adams,
383 U.S. 39, 50‒51 (1966)). The question of obviousness is resolved based
on underlying factual determinations including: (1) the scope and content of
the prior art; (2) any differences between the claimed subject matter and the
prior art; (3) the level of ordinary skill in the art; and (4) objective evidence
of non-obviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
In an inter partes review, a petition must identify “with particularity,
each claim challenged, the grounds on which the challenge to each claim is
based, and the evidence that supports the grounds for the challenge to each
claim.” 35 U.S.C. § 312(a)(3); see also 37 C.F.R. § 42.104(b) (2020)
(requiring a petition for inter partes review to identify how the challenged
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claim is to be construed and where each element of the claim is found in the
prior art patents or printed publications relied upon).
B. Level of Ordinary Skill in the Art
Petitioner argues that a person of ordinary skill in the art (POSA) at
the relevant times would have had a degree in engineering, biomedical
engineering, or a related discipline, along with relevant experience (at least
2–3 years for a Ph.D., 3–5 years for a Master’s, or greater than 5 years for a
Bachelor’s degree) researching or developing neural stimulation systems or
other implantable medical devices. Pet. 13–14 (citing Ex. 1008 ¶¶ 20–22).
Petitioner argues that a person of ordinary skill alternatively would have had
an M.D. and experience practicing as a neurologist, neurosurgeon or
anesthesiologist, with 2–3 years of experience in neural stimulation. Id.
at 14. Petitioner argues that the person would have had general knowledge
of implantable medical devices and various related technologies as of July
28, 2009. Id.
Patent Owner does not contest Petitioner’s definition of the ordinary
level of skill at this time but reserves the right to challenge Petitioner’s
formulation should trial be instituted. Prelim. Resp. 7.
For purposes of this Decision, we adopt Petitioner’s undisputed
definition.
C. Claim Construction
We construe each claim “in accordance with the ordinary and
customary meaning of such claim as understood by one of ordinary skill in
the art and the prosecution history pertaining to the patent.” 37 C.F.R.
§ 42.100(b). Under this standard, claim terms are generally given their plain
and ordinary meaning as would have been understood by a person of
ordinary skill in the art at the time of the invention and in the context of the
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entire patent disclosure. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed.
Cir. 2005) (en banc).
Petitioner provides the proposed constructions of the terms “based on
a relationship” and “computer-operable medium” that were argued in related
litigation. Pet. 14–15. Patent Owner does not propose any constructions and
argues that the Board need not adopt Petitioner’s argued constructions.
Prelim. Resp. 7.
We construe “based on a relationship” because it relates to a key
disputed limitation in this proceeding. See Vivid Techs., Inc. v. Am. Sci. &
Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (claims are construed only to
the extent necessary to resolve a dispute).
“based on a relationship”
According to Petitioner, Nevro argued in District Court that
“relationship” and “based on a relationship” were “non-technical, ordinary”
phrases. Pet. 14 (citing Ex. 1022). Boston Scientific argued in District
Court that “relationship” means “ratio or other scaling factor.” See id.
(citing Ex. 1001, 3:41–4:45, 7:3–15:18, Figs. 6–7). Boston Scientific argued
in District Court that “based on a relationship” means “using the product of
the magnitude of the first increment (i.e., the change to the waveform
parameter applied to the first electrode) and the relationship,” based on the
Specification. See Pet. 14–15 (citing Ex. 1001, 7:13–29, 10:66–11:36,
12:61–66, Fig. 4); Ex. 1022, 22–25. Petitioner argues that this is the only
way of setting the parameter for the second electrode disclosed in the
Specification. See id. Petitioner also argues that “Nevro also limited the
claims to this embodiment during prosecution.” Pet. 15 (citing id. § IV.C.).
Patent Owner argues that “Petitioner’s litigation-driven constructions
of ‘relationship’ / ‘based on a relationship’ were correctly rejected in district
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court and need not be adopted here.” Prelim. Resp. 7 (citing Ex. 2001, 5;
Ex. 2003, 133:17–135:15).
The District Court construed “based on a relationship” to have its
plain and ordinary meaning. Ex. 2001, 5.
We construe “based on a relationship” to have its plain and ordinary
meaning, in agreement with the District Court construction. We have
reviewed the cited portions of the Specification relied on by Boston
Scientific and determine that they do not rise to the level of a definition of
“relationship” or “based on a relationship” although the Specification
provides a definition for a specific “ratio.” See Ex. 1001, 7:13–29 (setting
the level of the waveform parameter applied to the second electrode based
on the magnitude of the change of the waveform parameter applied to the
first electrode and a relationship between the first therapy range and the
second therapy range), 10:66–11:36 (providing an equation with the ratio of
the first therapy range for the first area of the patient to the second therapy
range for the second area of the patient), 12:61–66 (method 70 includes
changing the first level of the waveform parameter and setting the second
level of the waveform parameter), Fig. 4 (schematic illustrations of
waveforms).
Petitioner also refers to the section of its brief on the prosecution
history and appears to argue that in related U.S. Patent Application
12/510,930 (“the ’930 Application”), the applicant amended the claims to
include a “mathematical relationship” and stated that “the claims should be
read to cover the embodiments of mathematical relationships described in
the specification and all equivalents thereof.” Pet. 12–13 (citing Ex. 1011,
197, 207–09).
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Whether or not that statement rises to the level of a clear and
unequivocal disclaimer in the ’930 Application, the term “mathematical
relationship” does not appear in the claims of the ’461 patent. Sanofi v.
Watson Laboratories Inc., 875 F.3d 636 (Fed. Cir. 2017) (“In general, a
prosecution disclaimer will only apply to a subsequent patent if that patent
contains the same claim limitation as its predecessor.”) (citation omitted).
Petitioner states that, although the ’461 patent claims lack the term
“mathematical relationship” which was present in the ’930 Application, the
Examiner referred to a “mathematical relationship” in the notice of
allowance for the ’461 patent. Pet. 12–13 (citing Ex. 1002, 99). We find the
Examiner’s notice of allowance to be insufficient evidence of an intent by
the applicant to limit the claims of the ’461 patent to a mathematical
relationship. See, e.g., Computer Docking Station Corp. v. Dell, Inc., 519
F.3d 1366 (Fed. Cir. 2008) (“a patentee may limit the meaning of a claim
term by making a clear and unmistakable disavowal of scope during
prosecution”) (citation omitted).
Whether or not a relationship can be mathematical (see Prelim.
Resp. 30), we do not find a clear and unmistakable disclaimer for the
’461 patent to limit the claim scope to a mathematical relationship.8 We,
therefore, agree with the District Court’s construction that “based on a
relationship” has its plain and ordinary meaning.

8 Even if the claims were limited to a “mathematical relationship,” this
would not change our conclusion that Petitioner has not shown a reasonable
likelihood of prevailing on its assertion as to any of the claims of the ’461
patent.
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D. Anticipation of Claims 1–4, 7, 8, and 10–17 by Meadows
Petitioner contends that claims 1–4, 7, 8, and 10–17 are anticipated by
Meadows. Pet. 16–50, 55–59. Patent Owner disagrees. See Prelim.
Resp. 34–51.
1. Meadows
Meadows is titled “Rechargeable Spinal Cord Stimulator System” and
relates to a spinal cord stimulation (SCS) system, which is a programmable
implantable pulse generating system used to treat chronic pain by providing
electrical stimulation pulses from an electrode array placed epidurally near a
patient’s spine. Ex. 1003, code (54), 1:9–13.
Meadows discloses that its SCS system provides a stimulus to a
selected pair or group of a multiplicity of electrodes, e.g., 16 electrodes,
grouped into multiple channels, e.g., four channels. Id. at 2:46–50. Each
electrode is able to produce a programmable constant output current of at
least 10 mA over a range of output voltages that may go as high as 16 volts.
Id. at 2:50–52. In a preferred embodiment, the implant portion of the SCS
system includes a rechargeable power source, e.g., a rechargeable battery
that allows the patients to go about their daily business unfettered by an
external power source and controller. See id. at 2:54–57.
Meadows discloses that, as a feature of its system, each of the
electrodes included within the stimulus channels may not only deliver up to
12.7 mA of current over the entire range of output voltages, but also may be
combined with other electrodes to deliver even more current. Id.
at 2:65–3:2.
Meadows discloses, in one embodiment, that the SCS system provides
the ability to stimulate simultaneously on all available electrodes. Id. at 3:2–
4. Each electrode is grouped with at least one additional electrode. Id. at
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3:4–5. In one embodiment, such grouping is achieved by a low impedance
switching matrix that allows any electrode contact or the system case (which
may be used as a common, or indifferent, electrode) to be connected to any
other electrode. Id. at 3:5–9.
In another embodiment, Meadows discloses programmable output
current DAC’s (digital-to-analog converters) are connected to each electrode
node, so that, when enabled, any electrode node can be grouped with any
other electrode node that is enabled at the same time, thereby eliminating the
need for the low impedance switching matrix. Id. at 3:9–14. This feature
thus allows the clinician to provide unique electrical stimulation fields for
each current channel. Id. at 3:14–17.
Meadows discloses that, whichever type of lead and electrode array is
used, an important feature of its SCS system is the ability to support more
than one lead with two or more channels. Id. at 10:20–23. Here, a
“channel” is defined as a specified electrode, or group of electrodes, that
receive a specified pattern or sequence of stimulus pulses. Id. at 10:23–25.
Where more than one “channel” is available, each channel may be
programmed to provide its own specified pattern or sequence of stimulus
pulses to its defined electrode or group of electrodes. Id. at 10:25–29.
Meadows discloses that it is advantageous to have multiple channels,
for example, because left and right sides, or upper and lower extremities,
may require different stimulus parameter settings. Id. at 10:34–37.
Meadows discloses that monopolar and bipolar sensitivity (max and
min) thresholds may then be determined for each electrode for the displayed
electrode array configuration, with the aid of amplitude, rate (frequency),
and pulse width settings. Id. at 34:9–14.
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Meadows also states that “[i]n one embodiment, maximum and
minimum thresholds map to amplitude levels designated by numbers from 1
to 10 for each electrode (with respect to monopolar or bipolar or multipolar
configurations), as described in U.S. Patent Application Serial No.
60/172,167, filed Dec. 17, 1999[9], incorporated herein by reference.” Id.
at 34:14–19. Meadows also states that “details associated with programming
the IPG [implantable pulse generator] may be found in U.S. Pat. No.
6,052,624, U.S. patent application Ser. No. 09/550,217, filed Apr. 17,
2000[10]; and U.S. Patent Application Serial No. 60/172,167, filed Dec. 17,
1999, which patent and applications are incorporated herein by reference.”
Id. at 29:62–66.11
2. Analysis of Independent Claim 1
For the following reasons, we determine that Petitioner has not shown
a reasonable likelihood that Meadows discloses the limitation “automatically
set the waveform parameter applied to the second electrode based on a
relationship between the first therapy range and the second therapy range”
(limitation 1[h]).
Petitioner presents at least two “scenarios” of how it argues that
Meadows discloses limitation 1[h]. See Pet. 33–34. For the reasons set

9 Ex. 1012, hereinafter “Mann167.”
10 Ex. 1013, hereinafter “Mann217.”
11 In arguing for anticipation by Meadows, Petitioner also relies on the
disclosures of Mann167 and Mann217 as incorporated by reference. See
Pet. 19. Patent Owner argues that Meadows fails to incorporate the
disclosure from Mann217 relied on by Petitioner and reserves the right to
challenge Meadows’s incorporation of Mann167 in the event that the Board
institutes trial. Prelim. Resp. 38 n.8, 41–45. For purposes of this Decision,
and except as noted below, we need not decide the extent to which Meadows
incorporates by reference Mann217 and Mann167.
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forth below, we determine that these “scenarios” are hypothetical examples
constructed by Petitioner for how to program an IPG that lack an adequate
basis in Meadows. We will analyze each scenario in turn.
a) Petitioner’s asserted “scenario one”
First, Petitioner asserts a “scenario one”:
a user sends a command to change the amplitude for a channel
(e.g., from level 1 to 2), and the IPG changes the amplitude
applied to the first electrode in the channel (e.g., to its level 2
magnitude), and automatically sets the amplitude applied to the
second electrode (and any other electrodes) in the channel (e.g.,
to its level 2 magnitude) based on a therapy range ratio.
Pet. 33 (citing Ex. 1003, 5:48–60, 10:20–33, 18:41–53, 33:66–34:23,
35:5–62, 37:21–41, 38:41–56; Ex. 1012, 2:10–29, 6:18–7:8, 12:10–15:16,
16:3–18:2, 20:5–24:24, Figs. 3A–3B, 5–6). In other words, Petitioner is
referring to a scenario in which the IPG sets the amplitude of multiple
electrodes in the same electrode channel. See Ex. 1008 ¶ 102 (scenario
(1) when adjusting the magnitude level of a single channel containing the
first and second electrodes).12,13
Patent Owner argues that Petitioner fails to demonstrate that the
waveform parameter applied to the second electrode is based on the therapy
range of the first electrode because Petitioner fails to demonstrate that the
waveform parameter applied to the second electrode in Meadows or
Mann167 can be affected in any way by the therapy range for the first

12 We understand the channel to be a combination or set of electrodes.
13 Petitioner’s argued “scenario one” (see Pet. 33) is not referring to
sequential steps but rather to a command that simultaneously adjusts the
amplitude for each electrode in the channel. See Ex. 1008 ¶ 104. Indeed,
Mann167 simply applies an equalized magnitude level to all electrodes in
the same set. See Ex. 1012, 22:18–23:6.
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electrode. Prelim. Resp. 36–37 (citing Geospan Corp. v. Pictometry Int’l
Corp., No. CIV. 08-816 ADM/JSM, 2011 WL 1261583, at *6 (D. Minn.
Mar. 31, 2011), aff'd, 469 F. App’x 913 (Fed. Cir. 2012)).
We are persuaded by Patent Owner. Meadows refers to and
incorporates Mann167’s programming of electrodes, set at unit-less
magnitude levels 1–10. See Ex. 1003, 33:66–34:23. Mann167 discloses
setting magnitude levels 1 to 10 for each electrode, where the perception
threshold is set to magnitude level 1 and the maximum tolerable threshold is
set to magnitude level 10, with 8 steps in between. Ex. 1012, 6:18–7:8,
13:9–27. Claim 9 of Mann167 describes a method of (a) measuring a
perception threshold and a maximum tolerable threshold for each of n
electrode contacts; (b) equalizing those thresholds to unit-less magnitude
levels; (c) applying a stimulus having a selected equalized magnitude level
to a selected combination of n electrode contacts; (d) determining whether
the stimulus applied in step (c) produces a desired result and if not selecting
a different equalized magnitude level and repeating step (c); and (e) if the
stimulus applied in step (c) produces a desired result, then selecting the
stimulus parameters as the optimal set of stimulus parameters that are
programmed into the implantable neural stimulator. See Ex. 1012, 22:18–
23:6.
If and when step (d) causes Mann167 to repeat step (c), Mann167
changes the magnitude levels for each of the electrode contacts in the same
set of electrodes. Id. at 22:28–23:3. Although the ’461 patent provides an
express use of the therapy ranges of the first and second electrodes to set the
amplitude for each electrode when changing the amplitude for a first
electrode (see Ex. 1001, 10:55–11:16), Mann167 discloses no such
relationship. As Patent Owner states, Mann167 discusses generally how
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magnitude levels map to amplitude, but does not disclose any dependency or
relationship between electrodes. See Prelim. Resp. 37 (citing Ex. 1012,
13:10–14:20). Petitioner has not shown that Mann167 sets the amplitude for
the second electrode based on a relationship between a first electrode’s
therapy range and a second electrode’s therapy range, as opposed to using
another method to set the amplitude for a second electrode.
In this connection, we note that Mann167 provides the following
equation (1):
I = (M-P)/9E *(X-1) + P/E,
where X = Magnitude Level (0–10); I = mA for electrode (n); P = Perception
Threshold, mA; M = Maximum Threshold, mA; and E = number of cathodic
electrodes in a group. See Ex. 1012, 16:14–25. Mann167 states that
“Magnitude Level X remains constant for all electrodes that become selected
by the up/down input, while individual current levels are input for each
selected electrode based on the formula presented above. Id. at 17:2–5
(emphasis added). Thus, when Mann167 sets the magnitude of a given
electrode to a desired magnitude level, it may set the current based on the
therapy range of that electrode and the desired magnitude level (see id.
at 16:14–25, 17:2–5).14
Petitioner argues that the amplitude for the second electrode is set
based on a therapy range ratio of a first and second electrode, giving an
example: a therapy range of 2 to 8 mA for the first electrode at Area A1, and

14 There is a discussion in Mann167 of summing the amplitude levels for
adjacent electrodes assigned to a “virtual” cathode. See Ex. 1012, 17:6–27.
However, Petitioner did not provide reasoning in the text of the Petition
based thereon, and we find that such unexplained citations contained in
longer string cites to be an inadequate basis for Petitioner to rely on these
portions of Mann167.
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a therapy range of 3 to 7 mA for the second electrode at Area A2, resulting
in therapy range ratio or scaling factor S1 of 3:2 where S1 = (8–2)/(7-3) =
6/4 = 3/2. See Pet. 34 (citing Ex. 1012, 2:10–29, 12:10–14:20, 16:3–18:2;
citing Ex. 1008 ¶¶ 104–106). It is unclear from where Petitioner and
Petitioner’s expert derives this equation. Dr. Mihran appears to obtain the
numbers for the therapy ranges from the therapy ranges of electrode 1 and
electrode 2 in Figure 5 of Mann167. See Ex. 1008 ¶ 90 (discussing
limitation 1[d]). However, there is no disclosure of a scaling factor in
Mann167, and Dr. Mihran does not demonstrate that Mann167 necessarily
makes use of a scaling factor. Transclean Corp. v. Bridgewood Servs., Inc.,
290 F.3d 1364, 1373 (Fed. Cir. 2002) (“[A]nticipation by inherent disclosure
is appropriate only when the [single prior art] reference discloses prior art
that must necessarily include the unstated limitation.”). Nor does
Dr. Mihran explain how his equations would be derived from the equations
in Mann167.
Figure 5 of Mann167 is reproduced below:
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Figure 5 is a graph illustrating a representative stimulating current
distribution for first and second electrodes as a function of amplitude
(magnitude) level. Ex. 1012, 7:26–27. Figure 5 does show therapy ranges
of 2 mA to 8 mA for electrode 1, and 3 mA to 7 mA for electrode 2.
However, Mann167 does not show the use of a scaling factor to calculate the
current levels, as Petitioner argues.
There may be a relationship between the therapy range of the first
electrode and the second electrode inasmuch as the minimum thresholds are
equalized by being set equal to a magnitude level 1, and the maximum
thresholds are equalized by being set equal to a magnitude level 10, with a
linear increase for magnitude levels 2–9. Id. at 12:10–15:16. Thus, there
will always be a correlation between the amplitude levels for each electrode.
However, Petitioner has not shown that the amplitude for the second
electrode is set based on the therapeutic range for the first electrode.
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The portions of Mann167 relied on do not disclose a scaling factor or
otherwise show that a parameter for a second electrode is set based on a
relationship between therapy ranges. See Ex. 1012, 2:10–29 (discussing the
need for a neural stimulator where parameters may be met quickly and
safely), 12:10–14:20 (determining the magnitude levels for each electrode
set based on its minimum and maximum threshold), 16:3–18:2 (providing
equation (1) for a magnitude level, with current I, magnitude level X,
perception threshold P, maximum threshold M, and number of cathodic
electrodes E, where I = (M-P) (X-1)/9E + P/E; discussing virtual cathode
based on summation of electrode quantities)). Petitioner has provided
insufficient evidence and explanation to demonstrate that Mann167 makes
use of a scaling factor when it sets the current level of a second electrode, as
opposed to using other methods.
For completeness of discussion, we have reviewed the remaining
portions of Meadows cited by Petitioner and determine that they do not
disclose that a second electrode’s amplitude is set based on a relationship
between first and second therapy ranges. Rather, Meadows merely indicates
that each electrode is set to an amplitude corresponding to a desired level (1
to 10) where the therapy range (minimum to maximum) of that electrode is
divided into 10 steps. See Ex. 1003, 5:48–60 (the hand held programmer
may change the stimulus parameters), 10:20–33 (device has the ability to
support one lead with two or more channels), 18:41–53 (electrodes may be
assigned to groups and amplitudes on a channel may vary), 33:66–34:23 (an
electrode may have a threshold window with a minimum and a maximum,
and levels 1 to 10 for each electrode as described in Mann167), 35:5–62 (the
amplitude may be selected from 1 to 10), 37:21–41 (settings may be changed
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by telemetry), 38:41–56 (level 0 is off and level 1 is set to the sense
threshold).
Also for completeness of discussion, we have reviewed the remaining
portions of Mann167 cited by Petitioner and determine that they do not
disclose the recited relationship. See Ex. 1012, 6:18–7:8 (setting the
perception threshold as the minimum, setting the maximum tolerable
threshold as the maximum and assigning 10 levels), 12:10–15:16 (the
perception thresholds are equalized by mapping the perception threshold and
maximum tolerable threshold into unit-less “magnitude level” settings 1
and 10, with magnitude levels 2–9 set for a linear increase), 20:5–24:24
(claims 1–15 of Mann167), Figs. 3A–3B (showing therapeutic range for
each electrode a, b, c, and d, and magnitude levels 1–10 for each), 5–6
(showing tabular data and graphical data for electrodes 1 and 2).
We therefore determine that Petitioner has not made an adequate
showing that Meadows necessarily discloses limitation 1[h] by changing the
magnitude level of the electrodes in the same channel.
b) Petitioner’s asserted “scenario two”
Petitioner asserts a “scenario two”:
the IPG changes the amplitude applied to the first electrode in a
first channel (e.g., from level 1 to 2), and when the IPG
sequences to a second channel, it automatically sets the
amplitude applied to the second electrode in the second channel
(e.g., to its respective level 2 amplitude) based on a therapy range
ratio.
Pet. 33–34 (citing Ex. 1012, 2:10–3:25, 4:11–5:3, 12:10–14:20, 15:17–16:2,
18:19–19:5, Figs. 4–6). In other words, Petitioner is referring to a scenario
in which the IPG sets the amplitude of electrodes in different channels. See
Ex. 1008 ¶ 102 (scenario (2) when sequencing (or switching) stimulation
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from a first channel containing the first electrode to a second channel
containing the second electrode).
Patent Owner argues that Petitioner makes no attempt to explain how
the waveform parameter applied to a second electrode in a second channel is
automatically set “based on a relationship” between the second electrode’s
therapy range and any therapy range of an electrode in the first channel.
Prelim. Resp. 39–40.
We are persuaded by Patent Owner. As already discussed above with
respect to “scenario one,” Mann167 merely discloses equalizing the
magnitude level of the electrode contacts within a given selected
combination of electrode contacts. Ex. 1012, 4:11–5:3. Mann167 also
discloses equalizing the therapeutic range across electrode sets “a” through
“d.” Id. at 12:17–13:27, Figs. 3A, 3B.
However, Mann167 does not necessarily stimulate a second channel at
a magnitude level equal to a first channel, or based on any particular
relationship between the channels. Instead, Mann167 discloses
“sequenc[ing]” through selected electrode sets, or combinations of
electrodes, at “various” magnitude levels in order to determine which
combinations of electrodes and stimulus parameters produce a desired result.
Id. at 15:17–20. In any event, Petitioner has not shown that a second
electrode in a second set of electrodes (or channel) is set based on the
therapy range of a first electrode in a first set of electrodes (or channel), let
alone a relationship between first and second therapy ranges.15

15 Mann167 explains that its improvement is that “[b]y adjusting the
magnitude of the applied stimulus in terms of the ‘magnitude level’ number,
rather than the actual current value” “the fitting process (i.e., the process of
trying to locate the optimum stimulation parameters and electrode set) may
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Petitioner argues that “scenario two” makes use of the same scaling
factor or therapy range ratio that Petitioner asserts for “scenario one” (see
Pet. 34–35), but this argument fails for similar reasons. Petitioner has not
shown that Mann167 makes use of a scaling factor nor has Petitioner shown
how its proffered equations for a scaling factor may be derived from
Mann167’s disclosure.
We have reviewed the portions of Mann167 cited by Petitioner and
determine that they do not show setting a second electrode based on a
relationship between the therapy ranges of the first and second electrodes.
See Ex. 1012, 2:10–3:25 (background section indicates that there was a need
for a method of equalizing the perceived amplitude, and to thereby enable
quick, automated, and/or interactive (i.e., directional programming)
methods), 4:11–5:3 (same steps as claim 9 of Mann167 discussed above in
which step (c) of the method applies a selected equalized magnitude level to
a combination of n electrode contacts and step (d) of the method repeats step
(c) by applying a different equalized magnitude level), 12:10–14:20
(threshold data for sets “a” through “d,” once measured during an initial set
up period, are “equalized” so that the equalized threshold levels may
thereafter be used as further testing continues to determine the optimum
stimulus parameters), 15:17–16:2 (once the magnitude levels for each
electrode or electrode set have been determined, the IPG 30 is controlled so
as to sequence through selected electrode sets, or combinations of
electrodes, at various magnitude levels in order to determine which
combinations of electrodes and stimulus parameters produce a desired

be carried out much quicker and safer than has heretofore been possible.”
Ex. 1012, 15:25–16:1.
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result), 18:19–19:5 (programming system or method is advantageously
included as a key part of the invention whereby the perceived magnitude of
the applied stimuli is equalized in order to enable quick, automated, and/or
interactive selection of the stimulation parameter values that are used by the
stimulator), Fig. 4 (high level flowchart that depicts method as described
elsewhere, e.g., id. at 12:21–15:20), Figs. 5–6 (summation of electrode 1 and
electrode 2).
We therefore determine that Petitioner has not made an adequate
showing that Meadows necessarily discloses limitation 1[h] when switching
between channels.
c) Petitioner’s asserted interpolation of therapy ranges
Petitioner additionally asserts that Meadows, through incorporation by
reference of Mann217, discloses interpolating a therapy range for an
electrode placed between two other electrodes. Pet. 35–37. Petitioner’s
contentions are illustrated with further reference to the annotated figure
below.
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Figure 13 of Mann217, annotated by Petitioner, is provided above
with color added by Petitioner. Id. at 36. Petitioner asserts that the IPG can
interpolate the therapy range (in red) for the second electrode (in green) at
Area A2 based on a therapy range (in orange) (the “second therapy range”)
associated with Area A2 and a therapy range (in purple) (the “first therapy
range”) associated with Area A1. Id. at 35–36 (citing Ex. 1013, 28:4–29:3,
38:11–22, 40:7–20, 43:9–44:21; Ex. 1008 ¶ 107). Petitioner asserts that
once the interpolated therapy range (in red) is mapped to levels 1 to 10 and a
user adjusts from one level to another, the IPG will automatically set the
amplitude of the second electrode (in green) using the interpolated range
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derived from and set based on the first and second therapy ranges (in purple
and orange). Id. at 36.
Patent Owner argues that Petitioner fails to demonstrate how
interpolating therapy ranges discloses the claimed “based on a relationship”
requirement because Petitioner’s theory relies on different “second therapy
ranges” for different parts of the claims. Prelim. Resp. 45. Claim 1 recites
(i) “a second electrode associated with a second area of the patient, wherein
… the second area has a second therapy range for the waveform parameter,”
and (ii) “automatically set[ting] the waveform parameter applied to the
second electrode based on a relationship between the first therapy range and
the second therapy range.” Id.; Ex. 1001, 14:17–21, 14:29–31. Patent
Owner argues that the recited “second therapy range” is both (i) the therapy
range for the area that the “second electrode” is associated with, and also
(ii) part of the “relationship” used to set the waveform parameter for the
“second electrode.” Prelim. Resp. 45.
Patent Owner argues that Petitioner does not identify any “second
therapy range” that is both (i) the therapy range for the area that the “second
electrode” is associated with, and also (ii) part of the “relationship” used to
set the waveform parameter for the “second electrode.” Id. at 46. Patent
Owner also argues that Petitioner’s mapping of Mann217 to the claims
mapping implausibly relies on “Area A2” having multiple therapy ranges for
the same waveform parameter and Mann217 does not identify any area that
has more than one therapy range. Id. at 47–48.
We are persuaded by Patent Owner that Petitioner has failed to show
that a parameter for a second electrode is set based on a relationship between
a first therapy range and second therapy range, where the second electrode is
associated with a second area and the second area has a second therapy
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range. See Ex. 1001, 14:14–21, 14:29–31. Petitioner identifies the green
electrode as the second electrode, and the purple range as the first therapy
range. In order to rely on a first and second therapy range to determine the
therapy range in red for the second electrode (in green), Petitioner relies on
the orange therapy range as the second therapy range, but this is not
consistent with the claim language because the orange therapy range (the
argued second therapy range) is not associated with the second electrode and
this interpretation is therefore inconsistent with the claim language.
Summary of Claim 1
On the record at this stage of the proceeding, we determine that
Petitioner has not shown a reasonable likelihood that claim 1 of the
’461 patent is anticipated by Meadows.
3. Analysis of Remaining Claims
We determine that Petitioner has not shown a reasonable likelihood
that dependent claims 2–4, 7, 8, and 10 are anticipated by Meadows, for the
same reasons as independent claim 1.
Independent claim 11 contains similar language and requirements as
limitation [h] of independent claim 1. For the same reasons as independent
claim 1, we determine that Petitioner has not shown a reasonable likelihood
of prevailing on its assertion of anticipation by Meadows as to independent
claim 11 and its dependent claims 12–17.
E. Obviousness of Claims 1–8 and 10–17 over Meadows
To remedy the above-identified deficiency in Meadows as to
limitation 1[h], Petitioner’s assertion of obviousness of claim 1 over
Meadows is based on the disclosure of the ’461 patent that there were
conventional devices that automatically set a parameter for linked areas
having therapy ranges. See Pet. 37–39 (citing, e.g., Ex. 1008 ¶¶ 110–112).
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Petitioner argues that “no modification of the hardware is necessary to
program the claimed ‘relationship’—it is just math implemented in
programming and therefore a predictable design choice—a POSA would
have a reasonable expectation of success.” Id. Petitioner also asserts that
automatically setting the second electrode based on a “ratio … equal to 1:1”
(the claimed “relationship”) was also well-known, according to the
’461 patent. Pet. 38 (citing Ex. 1001, 3:14–18, 10:54–57, 13:59–63).
Patent Owner argues that the existence of linked mode systems,
however, in no way concedes that it was known to set a second waveform
parameter “based on a relationship” between first and second therapy ranges
as claimed. Prelim. Resp. 50. Patent Owner states that the cited portion of
the ’461 patent is from a section describing the invention of the ’461 patent,
explaining that “[t]he ratio of the first therapy range to the second therapy
range can be less than 1:1, equal to 1:1, or greater than 1:1 depending upon
the sizes of the individual ranges.” Id. (citing Ex. 1001, 10:54–57). Patent
Owner argues that this can hardly show it was known to set a second
waveform parameter “based on a relationship” between first and second
therapy ranges as claimed. Id.
We have reviewed the portions of the ’461 patent relied on by
Petitioner and find that they do not disclose setting a second electrode based
on a relationship between first and second therapy ranges. For example, the
’461 patent criticizes conventional linking mode systems that adjust the
amplitudes equally because different areas have different maximum
amplitude thresholds above which patients can experience pain. See
Ex. 1001, 3:14–18. This does not, however, disclose using the maximum
and minimum thresholds of therapy ranges to automatically set a parameter.
The ’461 patent discloses that the ratio of the first therapy range can be less
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than 1:1, equal to 1:1, or greater than 1:1 depending on the sizes of the
individual ranges. Id. at 10:54–57. We agree with Patent Owner that this
does not teach the use of a specific ratio, much less teach automatically
setting a parameter of a second electrode based on a relationship between
therapy ranges, as recited. The ’461 patent also states that existing linked
mode systems change the intensity of the waveform parameter at different
electrodes by equal increments or allow waveform parameters to be
decreased from their maximums by equal increments. Id. at 13:59–63. This
does not teach using a relationship between a first and second therapy range
to set a parameter.
Petitioner provides no persuasive evidence or argument why it would
have been obvious to modify Meadows to add the missing element, i.e.,
limitation 1[h]. Accordingly, we determine that Petitioner has not shown a
reasonable likelihood that independent claim 1 would have been obvious
over Meadows, for similar reasons as for its asserted ground of anticipation
by Meadows. Petitioner has not shown a reasonable likelihood that claims
2–8 and 10–17 would have been obvious over Meadows, for the same
reasons as independent claim 1.
F. Obviousness of Claims 1–8 and 10–17 over Meadows and John
Petitioner contends that claims 1–8 and 10–17 would have been
obvious over Meadows and John. Pet. 39–59. Patent Owner disagrees. See
Prelim. Resp. 51–54.
1. John
John is titled “Systems and Methods for Treating Disorders of the
Central Nervous System by Modulation of Brain Networks” and relates to
“modulation of the central nervous system for treating brain disorders and
more particularly to modulation of brain networks associated with
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undesirable aspects or symptoms of a patient’s brain disorder.” Ex. 1006,
code (54), ¶ 2.
John discloses that its system is intended to address the interactions
and connectivity that exists between different brain regions of a brain
network. See id. ¶ 8. John’s system provides deep brain stimulation
treatment that adjusts for the activation of multiple regions of a network
which may or may not be stimulated directly. Id. John’s system uses
neuromodulation methods that control (e.g., rebalance) the relative
activation levels of different areas of the network. Id.
John discloses that linking rules can be used to address the effects of
indirect or secondary stimulation. Id. ¶ 128. “Indirect stimulation” effects
can occur at locations which are sufficiently distal from the site of
stimulation that these areas are not directly stimulated by, for example, the
electrical field of a stimulator. Id. That being said, the use of linking rules
does not necessitate direct connectivity between the regions which are being
stimulated. Id. ¶ 129.
In one embodiment, neuromodulation of a network occurs by
modulating at least a first neural target region (i.e., NT1) and a second
neural target region (NT2), which are part of a network underlying, or
significantly correlated with, at least one characteristic of a disorder for
which treatment is being sought. Id. ¶ 131. One example of “linked
stimulation” is that when at least one stimulation parameter for stimulating
NT1, for example, voltage level, is increased by 1 volt then simultaneously
the neuromodulation of NT2 is increased by 0.5 volts. Id. Whenever NT1 is
additionally increased by 1 volt, then NT2 is increased by 0.5 volts. Id. The
“linking rule” is that Vnt2=Vntl *0.5, where Vntl is equal to the voltage
used at target NT1, and Vnt2 is equal to the voltage used at target NT2. Id.
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John discloses that linking rules are important because changes within
the network, that occur as side-effects in other regions due to stimulation of
a target structure, may aid, hinder, be irrelevant to, or may compensate for
neuromodulation treatment in the target region. Id. ¶ 133.
2. Analysis of Claim 1
Petitioner argues that John teaches “automatically adjusting
stimulation to a second area if the stimulation in a first area is adjusted by
the patient,” e.g., increasing the stimulation “proportionately for the two
areas, as defined by the linking rule.” Pet. 41 (citing Ex. 1006 ¶¶ 138, 144).
Petitioner argues that this means that, like in the ’461 patent, the first
increment for a first electrode is used in the “linking rule” to calculate and
automatically set the parameter applied to the second electrode. Id.
Petitioner argues that it would have been obvious to program
Meadows’ IPG using John’s “linking rule” technique to “automatically set
the waveform parameter applied to the second electrode based on a
relationship between the first therapy range and the second therapy range.”
Id. at 41 (citing Ex. 1008 ¶¶ 114–18). Petitioner argues that
Specifically, the combined teachings of Meadows and John
render obvious programming Meadows’ IPG with a “linking
rule,” so that when a user changes the amplitude of the first
electrode, the IPG automatically sets the amplitude applied to the
second electrode based on a therapy range ratio—e.g., according
to a “linking rule” that uses the product of the first increment and
the therapy range ratio.
Id. at 41–42.
Patent Owner argues that Petitioner fails to demonstrate, or even
assert, that John discloses automatically setting a second waveform
parameter “based on a relationship” between first and second therapy ranges.
Prelim. Resp. 52. Patent Owner argues that, at most, Petitioner alleges that
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John discloses automatically setting a second waveform parameter “based on
a relationship” between first and second waveform parameters, not therapy
ranges as claimed. Id.
We have reviewed the evidence relied on by Petitioner, and we are
persuaded by Patent Owner that John fails to disclose setting a second
waveform parameter “based on a relationship” between first and second
therapy ranges. The cited portions of John disclose that linking rules may be
used to adjust the stimulation at one target region to compensate for
cascading effects of stimulation of another region in a neural network and
show that a parameter may increase proportionally for the two areas but do
not disclose doing so based on first and second therapy ranges. Paragraph 9
of John discloses, e.g., “linking rules to adjust the stimulation provided at
one target region according to the neurostimulation provided at a different
target region, where both regions are part of a brain network.” Ex. 1006 ¶ 9.
Paragraph 20 of John discloses that John’s object is to provide a method of
neuromodulation which uses linking rules to link the neuromodulation
protocol of one stimulated area to those used at a different modulated area.
Id. ¶ 20. Paragraph 46 of John discloses evaluating sensed data and using it
to create a stimulation signal as may occur through control laws. Id. ¶ 46.
Paragraph 48 of John discloses that reference values may refer to values
determined by an equation, fixed values, or ratios. Id. ¶ 48. Paragraph 108
of John discloses that correlation analysis of data from brain networks can
be used to guide neurostimulation protocols, where the aim is not to increase
or decrease the overall level of activity, but rather to alter the timing and
correlation of activity between the two regions of the brain network. Id.
¶ 108. Paragraph 113 of John discloses that a treatment protocol can
incorporate information about the inter-region interactions. Id. ¶ 113. Cited
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paragraphs 127–140 of John consist of multiple paragraphs discussing, e.g.,
that there can be indirect stimulation of brain regions and providing
examples of linking rules where a first parameter is multiplied by a constant
to arrive at a second parameter. Id. ¶¶ 127–140. Paragraph 144 of John
discloses that patients can modify linking rules. Id. ¶ 144. Paragraphs 149–
150 of John disclose modulating at least a first region and a second region of
a brain network, wherein the stimulation protocol of a first region is
modified due to data sensed in, or stimulation that is provided at, at least a
second region of the network. Id. ¶¶ 149–150.
Thus, we agree with Patent Owner that John merely discloses
changing the parameter of a second electrode based on a parameter of a first
electrode, e.g., multiplied by a constant (see, e.g., id. ¶ 131), but does not
disclose setting a parameter of a second electrode based on a relationship
between first and second therapy ranges.
For these reasons, John does not remedy the deficiency in the asserted
ground of obviousness over Meadows. Accordingly, we determine that
Petitioner has not shown a reasonable likelihood that claim 1 is obvious over
Meadows and John.
3. Analysis of Remaining Claims
We determine that Petitioner has not shown a reasonable likelihood
that claims 2–8 and 10–17 are obvious over Meadows and John, for the
same reasons as independent claim 1.
G. Obviousness of Claims 6–8 over Meadows and Goetz;
Obviousness of Claims 6–8 over Meadows, John, and Goetz
Petitioner contends that claims 6–8 are obvious over Meadows and
Goetz, or over Meadows, John, and Goetz. Pet. 52–56. Patent Owner
disagrees. See Prelim. Resp. 54.
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1. Goetz
Goetz is titled “Therapy Programming Guidance Based on Stored
Programming History” and relates to “the delivery of therapy by medical
devices and, more particularly, to programming the delivery of therapy by
medical devices.” Ex. 1007, code (54), ¶ 2.
Goetz describes a problem with existing systems, i.e., printed records
and clinician memory of previous programming sessions are often absent or
inadequate, and provided little assistance in more quickly identifying
desirable programs during a current programming session. Id. ¶ 7. Goetz
discloses that programming history may be maintained or accessed by a
programming device used to program delivery of therapy to a patient by a
medical device, and may take the form of a record of programs, e.g.,
combinations of therapy parameters, tested during one or more prior
programming sessions. Id. ¶ 8. Goetz discloses that during a current
programming session, the programming device may retrieve information
relating to the extent or times of use for one or more programs that were sent
home with the patient. Id. ¶ 11.
2. Analysis of Claims 6–8
Petitioner does not rely on Goetz to remedy the above-identified
deficiency in the grounds of obviousness of independent claim 1 over
Meadows, alone or further in view of John. Accordingly, we determine that
Petitioner has not shown a reasonable likelihood that dependent claims 6–8
would have been obvious over Meadows and Goetz, or obvious over
Meadows, John, and Goetz, for the same reasons as for the grounds of
obviousness over Meadows and over Meadows and John.
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H. Anticipation of Claims 1–4, 7, 8, and 10–17 by Thacker16
Petitioner contends that claims 1–4, 7, 8, and 10–17 are anticipated by
Thacker. Pet. 59–69. Patent Owner disagrees. See Prelim. Resp. 54–56.
1. Thacker
Thacker is titled “System and Method For Converting Tissue
Stimulation Programs in a Format Usable by an Electrical Current Steering
Navigator” and relates “tissue stimulation systems, and more particularly, to
a system and method for programming an implantable tissue stimulator.”
Ex. 1004, code (54), 1:16–18.
Thacker discloses a method of programming a controller that controls
electrical stimulation energy output to a plurality of electrodes. Id. at 4:47–
48.
Thacker discloses, in the background section, that by reprogramming
an external control device, the stimulation region can often be moved back
to the effective pain site without having to reoperate on the patient in order
to reposition the lead and its electrode array. Id. at 3:9–12. Thacker also
discloses in the background section that an exemplary navigation table
(Appendix A), which includes a series of reference electrode combinations
(for a lead of 8 electrodes) with associated fractionalized current values
(i.e., fractionalized electrode configurations), can be used to gradually steer
electrical current from one basic electrode combination to the next, thereby
electronically steering the stimulation region along the leads. Id. at 3:41–47.

16 Petitioner argues together the grounds of anticipation by Thacker;
obviousness over Thacker; and obviousness over Thacker and Meadows.
See Pet. 62–69.
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Figure 21 of Thacker is reproduced below:

Figure 21 is a first navigator programming screen that can be
displayed by the computerized programming system of Figure 6 (not
reproduced here). Id. at 7:39–41. Actuation of navigator button 112 opens a
navigator screen 100(7) that allows a clinician to shift current between
multiple electrode combinations to fine tune and optimize stimulation
coverage for patient comfort. Id. at 17:17–20. Clicking on up and down
control arrows 204, 206 displaces horizontal bar 212, and thus location
designator 214, up and down within navigator scope 202, and clicking on the
left and right control arrows 208, 210 displaces location designator 214 left
and right along the horizontal bar 212. Id. at 17:28–33. In one embodiment,
the steering table in Appendix A is used to shift the cathodic and anodic
currents up and down along each lead 12 using simultaneously delivered
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pulses (and in this case, by using fractionalized current values in each row of
the steering table to generate stimulation in only one timing channel). Id.
at 18:4–9. For example, to gradually shift from a fractionalized current
value configuration of 100% cathodic current on electrode E1 and 100%
anodic current on electrode E3 to 100% cathodic current on electrode E1 and
100% anodic current on electrode E4, fractionalized electrode configurations
will be stepped through. Id. at 18:9–15.
Figure 15 of Thacker is reproduced below:

Figure 15 is a fifth operating room mapping screen that can be
displayed by the computerized programming system of Figure 6, particularly
showing an electrode combination in a manual mode. Id. at 7:17–20.
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A right arrow button can be clicked to incrementally increase the
pulse rate of the stimulation energy, and the left arrow of which can be
clicked to incrementally decrease the pulse rate of the stimulation energy.
Id. at 14:57–62. Notably, the adjustment of the pulse amplitude, pulse
width, and pulse rate will be performed globally for all of the electrodes
activated as either an anode (+) or a cathode (-). Id. at 14:62–65.
2. Analysis of Claim 1
Petitioner sets forth argument and evidence for its assertions that
claim 1 is anticipated by Thacker. Pet. 62–69. Patent Owner disagrees.
Prelim. Resp. 54–56.
Petitioner argues that Thacker incorporates Meadows and “thus
discloses and renders obvious these claims for the same reasons.” Pet. 59,
62 (citing Ex. 1004, 10:19–23). Petitioner argues that Thacker discloses an
SCS system like Meadows and adds “a third scenario” where an IPG is
programmed to automatically set the waveform parameter applied to the
second electrode based on a therapy range ratio—i.e., a “global” adjustment
feature that allows simultaneously changing and setting a parameter not only
across multiple electrodes, but also across multiple channels. Id. (citing
Ex. 1008 ¶¶ 161–197).
Petitioner argues that Thacker discloses (and renders obvious)17 this
third scenario in at least two ways: (1) Meadows’ system using Thacker’s
“global” adjustment feature, and (2) Thacker’s system using Meadows’
“therapy ranges.” Id.
Petitioner argues that Thacker provides a “global” adjustment feature
that allows the user to adjust a parameter (e.g., amplitude), automatically and

17 See n.16, supra.
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simultaneously, for two or more coverage areas based on a therapy range
ratio. Id. at 61–62 (citing Ex. 1004, 2:64–3:12, 15:10–67, 19:47–61,
20:24–30, Figs. 16–20). Petitioner argues that “the Thacker-Meadows IPG
can provide stimulation simultaneously on multiple channels.” Id. at 65
(citing Ex. 1004, 1:64–2:7, 2:64–3:12, 15:10–30).
Petitioner argues that “Thacker teaches that, by selecting a ‘global’
button, a user may select two or more coverage areas and ‘globally’ adjust a
parameter (e.g., amplitude) simultaneously for the electrodes in multiple
selected areas based on a therapy range ratio between those areas, as
explained for limitation [1h] in the Meadows grounds.” Pet. 66 (citing
Ex. 1004, 2:64–3:12, 14:57–65, 15:10–67, 19:47–61, 20:24–30, Figs. 16–20;
Ex. 1008 ¶ 181).
According to Petitioner:
When the user sends a change command to the Thacker-
Meadows IPG using “global” adjustment, the IPG is
programmed to change the parameter (e.g., amplitude) applied to
the first electrode in the first channel (e.g., from level 1 to 2), and
automatically set the parameter of the second electrode in the
second channel (e.g., amplitude at level 2) based on a therapy
range ratio (e.g., 3:2 ratio), as explained for limitation [1h] in the
Meadows grounds.
Pet. 67–68.
Patent Owner argues that, even if Thacker incorporates Meadows by
reference, Petitioner fails to demonstrate that the Thacker-Meadows
combination discloses automatically setting a second waveform parameter
“based on a relationship” between first and second therapy ranges. Prelim.
Resp. 56. Patent Owner argues that Petitioner relies on a channel-wide
change command (Thacker’s “global” adjustment) that changes the
parameters applied to two electrodes in parallel, and that Petitioner’s theory
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is almost exactly the same as Meadows’ “scenario one.” Id. Patent Owner
argues that Petitioner’s theory fails to demonstrate that Thacker or Meadows
discloses any dependency between an electrode’s waveform parameter and
another electrode’s therapy range, let alone that its waveform parameter is
automatically set “based on a relationship” between first and second therapy
ranges. Id.
We agree with Patent Owner that Thacker’s global adjustment
changes the parameters applied to two electrodes in parallel and that
Petitioner has not demonstrated that the waveform parameter for a second
parameter is necessarily set based on the relationship between first and
second therapy ranges as opposed to using another method.
We have reviewed the evidence relied on by Petitioner and find that
the cited portions do not demonstrate such a relationship. The cited portions
of Thacker disclose that parameters may be adjusted and may be combined
into a single stimulation program. See Ex. 1004, 2:64–3:12 (reprogramming
can move the treatment area without repositioning electrodes), 14:57–65
(adjustment of pulse amplitude, pulse width, and pulse rate can be performed
globally), 15:10–67 (example of parameters; multiple coverage areas can be
activated; the clinician can modify the electrical pulse parameters output by
the IPG to the electrode array for a selected coverage area; global button can
allow clinician to modify the pulse amplitude of selected coverage areas),
19:47–61 (can increase or decrease amplitude), 20:24–30 (groups of
stimulation parameter sets can be combined into a single stimulation
program), Figs. 16–20 (depicting screens). We therefore conclude that
Thacker’s global adjustment does not necessarily disclose that a parameter is
set for a second electrode based on the relationship between first and second
therapy ranges.
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Further, based on our discussion in Section II.D.2. above, Petitioner
has not shown how the use of Meadow’s therapy ranges would necessarily
disclose that a parameter is set for a second electrode based on the
relationship between first and second therapy ranges.
Accordingly, we determine that Petitioner has not shown a reasonable
likelihood that independent claim 1 is anticipated by Thacker.
3. Analysis of Remaining Claims
We determine that Petitioner has not shown a reasonable likelihood
that claims 2–4, 7, 8, and 10–17 are anticipated by Thacker, for the same
reasons as independent claim 1.
I. Obviousness of Claims 1–8 and 10–17 over Thacker;
Obviousness of Claims 1–8 and 10–17 over Thacker and Meadows
Petitioner sets forth argument and evidence for its assertions that
claims 1–8 and 10–17 are obvious over Thacker, alone or further in view of
Meadows. Pet. 62–69. Patent Owner disagrees. Prelim. Resp. 56–58.
1. Analysis of Claim 1
Petitioner’s contentions for obviousness over Thacker, alone or
further in view of Meadows, are similar to Petitioner’s contentions for
anticipation by Thacker. These grounds were grouped together in the
Petition. In addition to asserting that Thacker incorporates Meadows by
reference, Petitioner argues that a person of ordinary skill would have been
motivated to combine Meadows with Thacker. See Pet. 68.
Patent Owner argues that Petitioner fails to identify any specific
feature with respect to the combination of Thacker and Meadows, and
performs none of the analysis required to present a prima facie case of
obviousness. Prelim. Resp. 56–57 (citing TRW Automotive US LLC v.
Magna Elecs. Inc., IPR2014-00257, Paper 16 at 9–11 (PTAB June 26,
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2014)). Patent Owner argues that Petitioner’s challenge entirely fails to
explain what is missing from Meadows or Thacker and what it is proposing
to add. Id. at 57. Patent Owner argues that even if it would have been
obvious to incorporate “therapy ranges” from Meadows into Thacker or a
“global” command from Thacker into Meadows, Petitioner still would fail to
demonstrate that the Thacker-Meadows combination discloses setting a
waveform parameter “based on a relationship” with another electrode’s
therapy range, for the reasons provided elsewhere. Id. at 57 (citing id.
§§ V.B.1, VI.B).
For similar reasons as for the asserted ground of anticipation by
Thacker (which Petitioner asserts to incorporate Meadows), we determine
that Petitioner has not adequately shown that Thacker, alone or in
combination with Meadows, discloses limitation 1[h]. Petitioner provides
no persuasive evidence or argument why it would have been obvious to
modify Thacker to add the missing element, i.e., limitation 1[h].
Accordingly, we determine that Petitioner has not shown a reasonable
likelihood of prevailing on the asserted grounds.
2. Analysis of Remaining Claims
For the same reasons as for claim 1, we determine that Petitioner has
not shown a reasonable likelihood that claims 2–8 and 10–17 would have
been obvious over Thacker, alone or further in view of Meadows.
J. Obviousness of Claims 1–8 and 10–17 over Thacker and John;
Obviousness of Claims 1–8 and 10–17 over Thacker, Meadows, and
John
Petitioner contends that claims 1–8 and 10–17 are obvious over
Thacker, alone or further in view of Meadows, and further in view of John.
See Pet. 69–73. Patent Owner disagrees. Prelim. Resp. 56–59.
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Because we find that John does not remedy the deficiency in the
grounds of obviousness over Thacker, alone or further in view of Meadows,
we determine that Petitioner has not shown a reasonable likelihood that
claims 1–8 and 10–17 would have been obvious over Thacker, alone or
further in view of Meadows, and further in view of John.
K. Obviousness of Claims 6–8 over Thacker and Goetz;
Obviousness of Claims 6–8 over Thacker, Meadows, and Goetz;
Obviousness of Claims 6–8 over Thacker, John, and Goetz;
Obviousness of Claims 6–8 over Thacker, Meadows, John, and Goetz;
Petitioner does not rely on Goetz to remedy the above-identified
deficiencies in the grounds of obviousness of independent claim 1 over
Thacker, alone or further in view of one or more of Meadows and John.
Accordingly, Petitioner has not shown a reasonable likelihood that
dependent claims 6–8 would have been over Thacker, alone or further in
view of one or more of Meadows and John, and further in view of Goetz.
L. Anticipation of Claims 1–4 and 10–17 by Nolan18
Petitioner contends that claims 1–4 and 10–17 are anticipated by
Nolan. Pet. 73–80. Patent Owner disagrees. See Prelim. Resp. 59–61.
1. Nolan
Nolan is titled “Global Parameter Adjustment for Multiple Stimulation
Programs” and relates “to medical devices and, more particularly, to devices
that deliver electrical stimulation.” Ex. 1005, code (54), ¶ 1.
Nolan discloses that a patient may enter a single command into an
external programmer to make a parameter change on a “global” basis among
a plurality of stimulation programs. Id. ¶ 5. Nolan discloses that a

18 Petitioner interweaves its arguments for anticipation by Nolan and
obviousness over “Nolan, alone and with Meadows and/or John.” See
Pet. 76.
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multiprogram adjustment eliminates the need for the patient to manually
adjust the amplitude for each individual stimulation program. Id. ¶ 24.
Figure 8 of Nolan is reproduced below:

Figure 8 is a conceptual diagram illustrating an exemplary screen shot
associated with a group of stimulation programs with a pop-up screen
indicating a global parameter adjustment. Id. ¶ 20.
Global icon 102 indicates to patient 12 that a global adjustment has
been made, i.e., that the voltage amplitude for all programs in group A has
been changed. Id. ¶ 90. Parameter variable 104 indicates the number of
times patient 12 has selected to increase or decrease the voltage amplitude.
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In other words, parameter variable 104 is the number of increments or
decrements made to the voltage amplitude of each program in group A. Id.
Once the global adjustment has been initiated, processor 48
determines the adjustment range and step values for each program within the
group selected. Id. ¶ 94. Processor 48 then goes through the programs to be
adjusted. Id. If the program is not at a predetermined limit, processor 48
adjusts the voltage amplitude, or other specified parameter, one step. Id.
Nolan discloses that the step for each program may be of equal or
varying amplitude, dependent on the predetermined rules governing global
adjustment. Id. ¶ 56. In one embodiment, the step size is a function of the
adjustment range divided by the resolution. Id. ¶ 60.
In an alternative embodiment, the global adjustment may cause the
voltage amplitude of each stimulation program to change proportionately to
one another. In this embodiment, the global adjustment will change the
voltage amplitude of each stimulation program such that the ratios of each
voltage will remain constant while using the global adjustment. Id. ¶ 64. In
this embodiment, the step value of the selected program is calculated to
match the ratio of the first voltage amplitude values of each program in the
group so that the second voltage amplitudes of each program are
proportional to the first voltage amplitudes. Id. ¶ 65.
2. Analysis of Claim 1
Petitioner sets forth argument and evidence for its assertions that
claim 1 is anticipated by Nolan. Pet. 76–83. Patent Owner disagrees.
Prelim. Resp. 59–61.
Petitioner argues that Nolan teaches that electrodes, in any
combination, are grouped into “programs” having therapy ranges and
correlating to different areas, and the implantable medical device (IMD)
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provides stimulation simultaneously on multiple programs. Pet. 80 (citing
Ex. 1005 ¶¶ 5, 26, 48). Petitioner argues that, Nolan (like Thacker) teaches
that, with “global” adjustment, a user may select two or more programs and
“globally” adjust a parameter (e.g., amplitude) simultaneously for the
selected programs based on a therapy range ratio between those programs.
Id. (citing Ex. 1005 ¶¶ 5–6, 26, 52–69, 78–98, Figs. 4A–4B, 6–9; Ex. 1008
¶ 213. Petitioner asserts that Nolan discloses implementing “global”
adjustment in the IMD. Id. at 81 (citing Ex. 1005 ¶¶ 10, 48–49, 99,
claims 1–17, 32–38; Ex. 1008 ¶ 214).
Petitioner asserts that
[w]hen the user sends a change command to the IMD, it is
programmed to change the parameter applied to the first
electrode in the first program (e.g., from level 1 to 2), and
automatically set the parameter of the second electrode in the
second program (e.g., the amplitude at level 2) based on a ratio
of the first and second therapy ranges (e.g., 3:2 ratio), as
explained for limitation [1h] in the Meadows grounds.
Id. (citing Ex. 1008 ¶ 214).19

19 Petitioner asserts that in March 2018, the European Opposition Division
found a substantively identical claim to claim 1 of the ’461 patent lacked
novelty in view of Nolan. Id. at 74 (citing Ex. 1030, 1–4, 10; Ex. 1031).
Patent Owner also argues that the European Opposition Division finding is
not binding or relevant to whether Petitioner has satisfied its burden in this
proceeding. Id. at 60–61. In the European Opposition proceeding, an
interlocutory decision made a finding that a similar limitation to limitation
[1h] was known based on Nolan (Ex. 1030, 5, 7–8), and the patentee later
agreed to an amendment. Ex. 1031, 8. In any event, we note that the
European Opposition was based on a separate record with a separate set of
arguments, and although we take the European Opposition into
consideration, it is not binding. See, e.g., Walt Disney Co. v. Interactive
Toybox, LLC, IPR2019-00609, Paper 10 (PTAB Aug. 21, 2019) (interpreting
a claim differently than a corresponding claim in a corresponding EPO
decision).
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Patent Owner argues that, as with the anticipation grounds based on
Meadows and Thacker, Nolan’s change command fails to disclose setting a
waveform parameter “based on a relationship” with another electrode’s
therapy range because it fails to disclose any dependency between an
electrode’s waveform parameter and another electrode’s therapy range, let
alone that its waveform parameter is “based on a relationship” between first
and second therapy ranges. Prelim. Resp. 60.
We have reviewed the evidence and reasoning relied on by Petitioner
and determine that Petitioner has failed to demonstrate a reasonable
likelihood that Nolan discloses setting a parameter based on a relationship
between first and second therapy ranges, as required by limitation 1[h].
Petitioner asserts that Nolan discloses that a single command makes the
parameter change on a global basis among a plurality of stimulation
programs. See Pet. 80 (citing Ex. 1005 ¶¶ 5–6). Paragraph 5 of Nolan does
disclose the use of a single command to make the parameter change on a
global basis. Ex. 1005 ¶ 5. However, for similar reasons as for the asserted
grounds based on Meadows and Thacker, we determine that Petitioner has
not shown that the use of a single command to change parameters in parallel
necessarily means that a second electrode relies on the therapy range of a
first electrode, as opposed to using another method. Paragraph 6 of Nolan
discloses that each program may have a predetermined step value, a step
value calculated based upon a remaining possible adjustment range, or a step
value calculated for each stimulation program to keep parameter ratios equal
between the plurality of stimulation programs during the global adjustment.
Id. ¶ 6. However, Petitioner does not explain how keeping parameter ratios
equal necessarily means that a parameter of a second electrode is
automatically set based on the therapy range of a first electrode.
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Petitioner also does not adequately explain how the other proffered
evidence discloses the required relationship. Paragraph 26 of Nolan
discloses that programs may be delivered simultaneously or on a time-
interleaved basis. Id. ¶ 26. Paragraphs 48–49 of Nolan disclose that
adjustment instructions may include a set of rules and disclose wireless
telemetry. Id. ¶¶ 48–49. Cited paragraphs 52–69 of Nolan consist of
multiple paragraphs disclosing, e.g., that a range with a minimum and a
maximum may be divided into 10 steps; the step may be a fixed value;
alternatively the voltage amplitude of each program may change
proportionately to one another; the step value may vary; and the ratio used to
determine the step value for each of the other stimulation programs in the
group is based on the first voltage amplitude of each stimulation program.
Id. ¶¶ 52–69. Cited paragraphs 78–98 of Nolan consist of multiple
paragraphs discussing a computer interface. Paragraph 99 of Nolan
discloses a processor and memory for implementation. Id. ¶¶ 78–98. Cited
claims 1–17 and 32–38 of Nolan consist of multiple claims, where, e.g.,
claim 12 discloses the steps of determining an adjustment range for a
selected program; dividing the adjustment range for the selected program by
a resolution value to determine a respective step value; dividing an existing
parameter value for each of the other stimulation programs by the existing
parameter value for the selected program to determine a ratio for each of the
other stimulation programs; and multiplying the ratio for each of the other
stimulation programs by the step value to determine respective scaled
change values for each of the other stimulation programs, wherein applying
the adjustment includes applying the step value to the existing parameter
value for the selected program and applying the respective scaled change
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values to the existing parameter values for the other stimulation programs.
Id. at 10–12.
We agree with Patent Owner that, at most, Nolan describes a ratio of
parameter values multiplied by a step value as opposed to a relationship
between first and second therapy ranges. See Prelim. Resp. 62–63
(discussing obviousness over Nolan); Ex. 1005, claim 12.
Dr. Mihran’s declaration does not provide any further explanation of
how Nolan’s method would disclose setting a parameter of a second
electrode based on a relationship between first and second therapy ranges.
See Ex. 1008 ¶¶ 211–218. For example, Dr. Mihran states without further
explanation that limitation [1h] is met by a ratio of a first therapy range to
the second therapy range, e.g., 3:2, without explaining the basis for this
averment, other than a string citation to portions of Nolan. See Ex. 1008
¶ 214 (citing Ex. 1005 ¶¶ 10, 48–49, 99, claims 1–17, 32–38). As stated
above, we have already reviewed paragraphs 48–49 and 99 and claims 1–17
and 32–38 of Nolan. Paragraph 10 of Nolan discloses a computer readable
medium with instructions for applying an adjustment to a stimulation
parameter. Ex. 1005 ¶ 10.
We, therefore, determine that Petitioner has not adequately explained
how Nolan discloses limitation [1h]. Accordingly, we determine that
Petitioner has not shown a reasonable likelihood of prevailing on its
assertion that claim 1 of the ’461 patent is anticipated by Nolan.
3. Analysis of Remaining Claims
For the same reasons as independent claim 1, Petitioner’s has not
shown a reasonable likelihood that claims 2–4 and 10–17 are anticipated by
Nolan.
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M. Obviousness of Claims 1–8 and 10–17 over Nolan;
Obviousness of Claims 1–8 and 10–17 over Nolan and Meadows
Petitioner contends that claims 1–8 and 10–17 are obvious over
Nolan, alone or further in view of Meadows. See Pet. 80–83. Patent Owner
disagrees. See Prelim. Resp. 61–63.
Petitioner groups its arguments for the asserted grounds of
obviousness over Nolan and obviousness over Nolan and Meadows with the
asserted ground of anticipation by Nolan. Pet. 80–83. Petitioner
additionally argues that:
If Nevro argues that Nolan does not disclose the “based on
a relationship between the first therapy range and the second
therapy range” limitation, it would have been obvious to program
the Nolan IMD and Nolan-Meadows IMD, to automatically set
the parameter of the second electrode based on the claimed
relationship, e.g., setting the parameter in accordance with the
therapy range ratio or, alternatively, using the product of the first
increment and the therapy range ratio, for the same reasons in the
Meadows grounds.
Pet. 81–82 (citing id. § VII.B.[1h]; Ex. 1008 ¶ 216).
Petitioner provides no persuasive evidence or argument why it would
have been obvious to modify Nolan to add the missing element, i.e.,
limitation 1[h]. As set forth above, we determine that Petitioner has not
adequately shown that Meadows discloses limitation 1[h]. See Section
II.D.2. We determine that Petitioner has not shown that Nolan remedies the
deficiency in Meadows, for the same reasons as for the asserted ground of
anticipation by Nolan. Accordingly, we determine that Petitioner has not
shown a reasonable likelihood that claims 1–8 and 10–17 would have been
obvious over Nolan, alone or further in view of Meadows.
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N. Obviousness of Claims 1–8 and 10–17 over Nolan and John;
Obviousness of Claims 1–8 and 10–17 over Nolan, Meadows, and John
Petitioner contends that claims 1–8 and 10–17 are obvious over
Nolan, alone or further in view of Meadows, and further in view of John.
See Pet. 83–87. Patent Owner disagrees. Prelim. Resp. 63–64.
Because we find that John does not remedy the deficiency in the
grounds of obviousness over Nolan, alone or further in view of Meadows,
we determine that Petitioner has not shown a reasonable likelihood that
claims 1–8 and 10–17 would have been obvious over Nolan, alone or further
in view of Meadows, and further in view of John.
O. Obviousness of Claims 6–8 over Nolan and Goetz;
Obviousness of Claims 6–8 over Nolan, Meadows, and Goetz;
Obviousness of Claims 6–8 over Nolan, John, and Goetz;
Obviousness of Claims 6–8 over Nolan, Meadows, John, and Goetz;
Petitioner does not rely on Goetz to remedy the above-identified
deficiencies in the grounds of obviousness of independent claim 1 over
Nolan, alone or further in view of one or more of Meadows and John.
Accordingly, we determine that Petitioner has not shown a reasonable
likelihood that dependent claims 6–8 would have been obvious over Nolan,
alone or further in view of one or more of Meadows and John, and further in
view of Goetz.
III. CONCLUSION
We conclude that Petitioner has not shown a reasonable likelihood of
prevailing on its assertion that any of claims 1–8 and 10–17 of the
’461 patent are unpatentable. Because of this, we need not reach the other
issues raised by the parties, including the exercise of discretion under
35 U.S.C. §§ 314(a), 325(d).
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IV. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that the Petition is denied as to all challenged claims of
the ’461 patent and no trial is instituted.
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FOR PETITIONER:
Charles Rash
Jason Weil
Steven Maslowski
Brooks Kenyon
AKIN GUMP STRAUSS HAUER & FELD LLP
brandon.rash@akingump.com
jweil@akingump.com
smaslowski@akingump.com
bkenyon@akingump.com

FOR PATENT OWNER:

Ching-Lee Fukuda
Thomas A. Broughan III
SIDLEY AUSTIN LLP
clfukuda@sidley.com
tbroughan@sidley.com

Jon Wright
STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
Jwright-PTAB@skgf.com
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